A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)
2017年5月16日 更新者：Hoffmann-La Roche
A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
研究概览
研究类型
介入性
注册 (实际的)
52
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Moscow、俄罗斯联邦、115522
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Moscow、俄罗斯联邦、119991
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Alberta
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Calgary、Alberta、加拿大、T3B 6A8
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Ontario
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Ottawa、Ontario、加拿大、K1H 8L1
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Toronto、Ontario、加拿大、M5G 1X8
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Monterrey、墨西哥、64460
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RJ
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Rio de Janeiro、RJ、巴西、20551-030
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Rio de Janeiro、RJ、巴西、21941-912
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SP
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Sao Paulo、SP、巴西、05403-000
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Sao Paulo、SP、巴西、22793-080
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Berlin、德国、13353
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Freiburg、德国、79106
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Sankt Augustin、德国、53757
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Lazio
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Roma、Lazio、意大利、00165
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Liguria
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Genova、Liguria、意大利、16147
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Toscana
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Firenze、Toscana、意大利、50139
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Le Kremlin Bicêtre、法国、94275
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New South Wales
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Westmead、New South Wales、澳大利亚、2145
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Victoria
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Parkville、Victoria、澳大利亚、3052
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Connecticut
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Hartford、Connecticut、美国、06106
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Illinois
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Chicago、Illinois、美国、60637
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Chicago、Illinois、美国、60611
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New Jersey
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Hackensack、New Jersey、美国、07601
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North Carolina
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Charlotte、North Carolina、美国、28203
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Durham、North Carolina、美国、27710
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Ohio
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Cincinnati、Ohio、美国、45229-3039
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Oklahoma
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Tulsa、Oklahoma、美国、74135
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Utah
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Salt Lake City、Utah、美国、84109
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Washington
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Seattle、Washington、美国、98105
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Bristol、英国、BS2 8BJ
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Liverpool、英国、L12 2AP
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Madrid、西班牙、28046
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Madrid、西班牙、28034
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Barcelona
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Esplugas de Llobregat、Barcelona、西班牙、08950
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Buenos Aires、阿根廷、1270
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening
- Diagnosis of pJIA according to International League of Associations for Rheumatology classification
- Rheumatoid factor (RF)-positive pJIA
- RF-negative pJIA
- Extended oligoarticular JIA with a polyarticular course
- History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX)
- Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected
- Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids are permitted at the discretion of the investigator
- Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
- Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
- Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
- pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 [JADAS-71] less than or equal to (< / =) 3.8)
- Participants who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
- Lack of recovery from recent surgery or an interval of <6 weeks since surgery at the time of the screening visit
- Females who are pregnant, lactating, or intending to become pregnant during study conduct
- Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study
- Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
- History of alcohol, drug, or chemical abuse within 6 months of screening
- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit
- Positive purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice
- History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit
- Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
- History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
- History of or current cancer or lymphoma
- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin
- Active uveitis at screening
- Inadequate hematologic, renal or liver function
- Prior stem cell transplant at any time
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：TCZ SC 162 mg Q3W
Participants with body weight less than (<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
其他名称：
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实验性的：TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Minimum Serum Concentration (Cmin) of TCZ at Steady State
大体时间：Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
大体时间：Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
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Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Maximum Serum Concentration (Cmax) of TCZ at Steady State
大体时间：Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Serum Interleukin-6 (IL-6) Levels
大体时间：Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset.
It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in Soluble IL-6 Receptor Levels
大体时间：Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in C-Reactive Protein (CRP) Levels
大体时间：Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
大体时间：Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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The ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline indicates improvement.
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Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
大体时间：Baseline up to Week 52
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Baseline up to Week 52
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年7月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2013年6月14日
首先提交符合 QC 标准的
2013年7月17日
首次发布 (估计)
2013年7月22日
研究记录更新
最后更新发布 (实际的)
2017年6月14日
上次提交的符合 QC 标准的更新
2017年5月16日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.